NCT05376176

A Multicenter Study Assessing the Efficacy and Safety of STN1010904 Ophthalmic Suspension 0.03% and 0.1% Compared With Vehicle in Subjects With Fuchs Endothelial Corneal Dystrophy (FECD)

A Phase IIa, Randomized, Double-Masked, Placebo-Controlled, Parallel-Group, Multicenter Study Assessing the Efficacy and Safety of STN1010904 Ophthalmic Suspension 0.03% and 0.1% Compared With Vehicle in Subjects With Fuchs Endothelial Corneal Dystrophy (FECD) - PHANTOM Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: Santen Inc. · Industry
• Sex: All
• Age: 30 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase IIa study to assess efficacy and safety of STN1010904 ophthalmic suspension (0.03%, and 0.1 %), twice daily dosing when compared to Placebo in subjects diagnosed with Fuchs Endothelial Corneal Dystrophy (FECD). This study will consist of a Screening Period of up to 15 days and an 18-month Double-Masked Treatment Period, including 9 individual visits to the study site.

Conditions

• Fuchs Endothelial Corneal Dystrophy

Interventions

Type	Name	Description
DRUG	STN1010904 ophthalmic suspension 0.03% BID	0.03% STN1010904 ophthalmic suspension BID
DRUG	STN1010904 ophthalmic suspension 0.1% BID	0.1% STN1010904 ophthalmic suspension BID
DRUG	Placebo (Vehicle) BID	Placebo (vehicle) BID

Timeline

• Start date: 2022-05-19
• Primary completion: 2025-05-26
• Completion: 2025-05-26
• First posted: 2022-05-17
• Last updated: 2025-07-15

Locations

15 sites across 3 countries: United States, France, India

Regulatory

• FDA-regulated drug study